DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Terminal Disclaimer
The terminal disclaimer filed on March 6, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on US Application No. 17/488,623 and 17/263,776 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,138,157. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a valve frame, prosthetic valve leaflets, and a plurality of chord recruiting arms and a delivery method comprising deploying the chord recruiting arms in a rotational configuration extending radially from the ventricular portion of the valve frame and curving in a circumferential direction, and rotating the valve frame as claimed. The difference between claims of the instant application and the claims of the patent lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims are in effect a “species” of the “generic” invention of the instant application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, and 6-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raanani (US 2015/0173897, hereinafter “Raanani”).
Regarding claim 1, Raanani discloses an apparatus for use a native atrio-ventricular valve (24) that is disposed between an atrium and a ventricle of a heart of a subject, the native atrio-ventricular valve including a valve annulus, valve leaflets, chords, and papillary muscles (Figs 8-11; abstract), the apparatus comprising:
a valve frame (10) that defines a ventricular portion (32) that is configured to be implanted within the ventricle (para [0120-0129, 0180]; Figs 29A-B);
prosthetic valve leaflets (49) disposed within and coupled to the valve frame (para [0183]);
a plurality of chord-recruiting arms (34) coupled to the ventricular portion of the valve frame; and
a delivery device (deployment system 50) configured to: deliver the valve frame to the native atrio-ventricular valve while maintaining the valve frame in a radially-constrained configuration (Figs 8-9; para [0243-0246]), subsequently, deploy the chord-recruiting arms (34) among the chords of the native atrio-ventricular valve in a rotational configuration of the chord-recruiting arms, in which the chord-recruiting arms extend at least radially from the ventricular portion of the valve frame and curve in a circumferential direction, while the chord-recruiting arms are deployed among the chords of the native atrio- ventricular valve: initially rotate at least a portion of the valve frame in an opposite circumferential direction from the circumferential direction in which the chord- recruiting arms curve; and subsequently, rotate at least the portion of the valve frame in the circumferential direction in which the chord-recruiting arms curve (para [0250-0253]; Figs 10, 14, 30A-31I; valve frame is fully capable of being rotated in both a clockwise and counter-clockwise direction by a user).
Regarding claim 4, wherein a tip of each of the chord-recruiting arms (34) is rounded such as to guide chords around the tip of the chord-recruiting arm without damaging tissue (para [0253, 0262-0265]; see rounded tips in at least Figs 3B, 3D, 5B, 6B, 14).
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Regarding claim 6, wherein the chord-recruiting arms (34) are configured to define the rotation configuration, in response to being released from the delivery device while a portion of the valve frame is maintained in an at least partially radially constrained configuration within the delivery device (Figs 3B; 10, 14, 30A-31I; para [0250-0253]).
Regarding claim 7, wherein, in the rotation configuration of the chord- recruiting arms, an outer surface of each of the chord-recruiting arms has a smooth, convex curvature that extends along substantially a full length of the chord-recruiting arm, such that during rotation of at least a portion of the valve frame in the opposite circumferential direction from the circumferential direction in which the chord-recruiting arms curve, chords slide over the outer surface of the chord-recruiting arm without be recruited or caught by the chord-recruiting arm (Figs 3B; 10, 14, 30A-31I; para [0250-0253]; see annotated Fig 3B below).
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Regarding claim 8, wherein, in the rotation configuration of the chord- recruiting arms, an inner surface of each of the chord-recruiting arms has a concave curvature, such that during rotation of at least the portion of the valve frame in the circumferential direction in which the chord-recruiting arms curve, the chords are recruited within a space defined by the concave curvature (Figs 3B; 10, 14, 30A-31I; para [0250-0253]; see annotated Fig 3B above).
Regarding claim 9, wherein the delivery device is configured to recruit and deflect at least the portion of the chords with the chord-recruiting arms, by rotating at least the portion of the valve frame in the circumferential direction in which the chord-recruiting arms curve (Figs 3B; 10, 14, 30A-31I; para [0250-0266]).
Regarding claim 10, wherein the delivery device is configured to pull the native atrio-ventricular valve radially inward toward the valve frame, by recruiting and deflecting at least the portion of the chords with the chord-recruiting arms (Figs 3B; 10, 14, 30A-31I; para [0250-0266]).
Regarding claim 11, wherein the delivery device is configured to twist the native atrio-ventricular valve around the valve frame, by recruiting and deflecting at least the portion of the chords with the chord-recruiting arms (Figs 3B; 10, 14, 30A-31I; para [0250-0266]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raanani (US 2015/0173897), as applied to claim 1 above, further in view of Patel et al. (US 2018/0177594, hereinafter “Patel”).
Raanani discloses the invention substantially as claimed, as shown above, and further teaches the chord-recruiting arms (34) are designed to be smooth (para [02553]) and fabric may cover at least a portion of the frame (para [0105]). However, Raanani fails to disclose wherein the outer or inner surface of each of the chord- recruiting arms is covered with a low-friction fabric, such as to allow movement of the outer surface with respect to the chords without damaging tissue. Patel discloses a similar device for treating a native atrio-ventricular valve (abstract) and teaches adding a low friction ePTFE cover layer (1170) to help with interactions between the device and native heart tissue (para [0157, 0159]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raanani such that a low-friction fabric or ePTFE cover layer covered the outer and/or inner surfaces of the chord-recruiting arms to allow the chord recruiting arms to more easily slide through the native chords while being positioned and improving the atraumatic feature of the arms.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raanani (US 2015/0173897), as applied to claim 1 above, further in view of Murphy et al. (US 2014/0031928, hereinafter "Murphy"). Raanani discloses the invention substantially as claimed, as shown above, but fails to disclose wherein a tip of each of the chord-recruiting arms is cushioned such as to guide chords around the tip of the chord-recruiting arm without damaging tissue. Murphy discloses a similar device (1) for treating a native atrio-ventricular valve (abstract) and teaches adding cushioning buffers (140, 141) or barriers on the device, wherein the cushion "forms a pad or buffer between the device and the wall of the heart to ameliorate abrasion of the heart by
the device 1" (para [0153], Fig 23). Therefore, it would have been obvious to one of ordinary
skill in the art before the effective filing date of the claimed invention to modify the device of
Raanani such that a tip of each of the chord-recruiting arms was cushioned to form a pad or
buffer between the chord-recruiting tip and the native tissue and to ameliorate abrasion of the
heart by the device. In the modified embodiment, it would be obvious the cushioned tips would
guide chords (22) around the tip of the chord-recruiting arm without damaging tissue.
Claim(s) 12, 15, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raanani (US 2015/0173897) in view of Brown et al. (US 2018/0206992, hereinafter “Brown”).
Regarding claim 12, Raanani discloses a method for use with a native atrio-ventricular valve (24) that is disposed between an atrium and a ventricle of a heart of a mammalian subject, the native atrio-ventricular valve including a valve annulus, valve leaflets, chords, and papillary muscles (Figs 8-11; abstract) substantially as claimed, the method comprising:
delivering to the native atrio-ventricular valve (24): a valve frame (10) that defines a ventricular portion (32) that is configured to be implanted within the ventricle (para [0120-0129, 0180]; Figs 29A-B), valve leaflets (49) disposed within and coupled to the valve frame (para [0183]), and a plurality of chord-recruiting arms (34) coupled to the ventricular portion of the valve frame;
and deploying the chord-recruiting arms (34) among the chords (22) of the native atrio-ventricular valve (24) while the chord-recruiting arms are in a rotational configuration, in which the chord-recruiting arms extend at least radially from the ventricular portion (32) of the valve frame and curve in a circumferential direction; while the chord-recruiting arms are deployed among the chords of the native atrio-ventricular valve: initially rotate at least a portion of the valve frame; and subsequently, rotate at least the portion of the valve frame in the circumferential direction in which the chord-recruiting arms curve (Figs 3B; 10, 14, 30A-31I; para [0250-0266]).
Raanani teaches prior to rotating the valve frame in a given direction to recruit and deflect at least a portion of the native chords and thereby capture the native valve, the arms may be first “repeatedly partially deployed, optionally rotated, and then retracted again; until the operator is satisfied that the arms 34 are deployed to a position which is sufficient to encounter the chords of the mitral valve and recruit them for prosthetic valve fixation” (para [0253]). However, Raanani fails to specifically disclose performing the initial rotation of at least the portion of the valve frame is in an opposite circumferential direction from the direction of circumferential curvature of the chord-recruiting arms. Brown discloses a similar device with a plurality of chord recruiting arms (35) configured to extend radially outward and having a curved configuration to capture native chords (76) of an atrio- ventricular valve (Fig 7; para [0047, 0051-0053]). Brown teaches rotating the chord recruiting arms in a first direction and if it is determined that the position of the device is not sufficient, rotating the chord recruiting arms in a second opposite direction to release the device and subsequently rotate the chord recruiting arms in the first direction again to properly capture the native chords (para [0006, 0051, 0062, 0064]). Thus, Brown recognizes rotating in the opposite circumferential direction is beneficial to release any native chords that me unintentionally tangled or captured in the chord recruiting arms. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Raanani such that the step of repeatedly partially deploying, optionally rotating, and retracting the arms again until the operator is satisfied with a sufficient position of the arms to encounter the chords comprised rotating at least a portion of the valve frame in an opposite circumferential direction from the direction of circumferential curvature of the chord-recruiting arms to be able to release the arms from the native chords and allow the arms to be retracted prior to being redeployed. It is obvious that during the rotation of at least the portion of the valve frame in the opposite circumferential direction from the direction of circumferential curvature of the chord- recruiting arms in the modified method, chords slide over the outer surface of the chord-recruiting arm without being recruited or caught by the chord-recruiting arm due to the structure of the smooth convex curvature. Furthermore, it would have been prima facie obvious to try modifying the method of Raanani such that the valve frame was rotated in either direction, including being rotated in an opposite circumferential direction before attempting to recruit the chords by rotating the portion of the valve frame in the direction of circumferential curvature of the chord-recruiting arms to release any native chords that me unintentionally tangled or captured in the chord recruiting arms in an attempt to provide an improved method for delivering a valve frame to a native atrio-ventricular valve as one with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions (rotation in circumferential direction or opposite circumferential direction) with a reasonable expectation of success.
Regarding claim 15, wherein a tip of each of the chord-recruiting arms (34) is rounded such as to guide chords around the tip of the chord-recruiting arm without damaging tissue (para [0253, 0262-0265]; see rounded tips in at least Figs 3B, 3D, 5B, 6B, 14).
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Regarding claim 17, wherein rotating at least the portion of the valve frame in the circumferential direction in which the chord-recruiting arms curve comprises recruiting and deflecting at least the portion of the chords with the chord-recruiting arms, to thereby pull the native atrio-ventricular valve radially inward toward the valve frame and twist the native atrio- ventricular valve around the valve frame chords (Figs 8-11, 30A-E; para [0252-0271]).
Regarding claim 18, wherein deploying the chord-recruiting arms among the chords of the native atrio-ventricular valve while the chord-recruiting arms are in the rotational configuration comprises releasing the chord-recruiting arms from the delivery device while a portion of the valve frame is maintained in an at least partially radially constrained configuration within the delivery device (Fig 30C; para [0251-0253] – chord recruiting arms may deploy or at least partially deploy and be rotated while cylindrical part is radially-constrained within overtube 63).
Regarding claim 19, wherein, in the rotation configuration of the chord- recruiting arms, an outer surface of each of the chord-recruiting arms has a smooth, convex curvature that extends along substantially a full length of the chord-recruiting arm, such that during rotation of at least a portion of the valve frame in the opposite circumferential direction from the circumferential direction in which the chord-recruiting arms curve, chords slide over the outer surface of the chord-recruiting arm without be recruited or caught by the chord-recruiting arm (Figs 8-11, 30A-E; para [0252-0271]; see annotated Fig 3B below).
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Regarding claim 20, wherein, in the rotation configuration of the chord- recruiting arms, an inner surface of each of the chord-recruiting arms has a concave curvature, such that during rotation of at least the portion of the valve frame in the circumferential direction in which the chord-recruiting arms curve, the chords are recruited within a space defined by the concave curvature (Figs 8-11, 30A-E; para [0252-0271]; see annotated Fig 3B above).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raanani (US 2015/0173897) and Brown (US 2018/0206992), as applied to claim 12 above, further in view of Patel (US 2018/0177594).
Raanani and Brown disclose the invention substantially as claimed, as shown above. Raanani further teaches the chord-recruiting arms (34) are designed to be smooth (para [02553]) and fabric may cover at least a portion of the frame (para [0105]). However, Raanani fails to disclose wherein the outer or inner surface of each of the chord- recruiting arms is covered with a low-friction fabric, such as to allow movement of the outer surface with respect to the chords without damaging tissue. Patel discloses a similar device for treating a native atrio-ventricular valve (abstract) and teaches adding a low friction ePTFE cover layer (1170) to help with interactions between the device and native heart tissue (para [0157, 0159]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Raanani such that a low-friction fabric or ePTFE cover layer covered the outer and/or inner surfaces of the chord-recruiting arms to allow the chord recruiting arms to more easily slide through the native chords while being positioned and improving the atraumatic feature of the arms.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raanani (US 2015/0173897) and Brown (US 2018/0206992), as applied to claim 12 above, further in view of Murphy (US 2014/0031928). Raanani and Brown disclose the invention substantially as claimed, as shown above, but fail to disclose wherein a tip of each of the chord-recruiting arms is cushioned such as to guide chords around the tip of the chord-recruiting arm without damaging tissue. Murphy discloses a similar device (1) for treating a native atrio-ventricular valve (abstract) and teaches adding cushioning buffers (140, 141) or barriers on the device, wherein the cushion "forms a pad or buffer between the device and the wall of the heart to ameliorate abrasion of the heart by the device 1" (para [0153], Fig 23). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Raanani and Brown such that a tip of each of the chord-recruiting arms was cushioned to form a pad or buffer between the chord-recruiting tip and the native tissue and to ameliorate abrasion of the heart by the device. In the modified embodiment, it would be obvious the cushioned tips would guide chords (22) around the tip of the chord-recruiting arm without damaging tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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